第1回 肝毒性及び薬物安全性

前臨床段階における予測の向上と薬物性肝障害の防止 : カタログダウンロード(英語版PDF)

5月13日(火) 〜 14日(水)

基調パネルディスカッション: 薬物の安全性: 2020年へ向けてのビジョン

Wendy R. Sanhai, Ph.D., Senior Scientific Advisor, Office of the Commissioner, FDA
Medical Product Development: Addressing Scientific Hurdles Through Strategic Partnerships with Stakeholders

Arthur L. Holden, Chairman and CEO, International Serious Adverse Event Consortium, Ltd.
Formation of an International Effort to Understand the Genetic Basis of Drug Related Serious Adverse Events

Peter J. Pitts, President, Center for Medicine in the Public Interest
The Unintended Consequences of Safety

前臨床スクリーニングの戦略

Chairperson
William B. Mattes, Ph.D., DABT, Director, Toxicology, The Critical Path Institute

Improvements in In Vitro and In Vivo Screening Techniques Using Human Hepatoma (HepG2) Cells
Firouz Darroudi, M.D., Ph.D., Department of Toxicogenetics, Leiden University Medical Centre, The Netherlands

Metabonomics Evaluations of Urine Samples from Multiple Liver Toxicity Studies in Rats
Richard Beger, Ph.D., Branch Chief, Center for Metabolomics, Division of Systems Toxicology, National Center for Toxicological Research

New Preclinical Screens to Detect Drug-Induced Mitochondrial Dysfunction Yield a New Model of Idiosyncratic Organ Toxicity
James Dykens, Ph.D., Senior Principal Scientist, Drug Safety R&D, Pfizer Inc.

肝毒性スクリーンの予測ツール

Detection of Drug-Induced Liver Toxicity in Early Drug Discovery Process Using Toxicogenomics Approach
Yi Yang, Ph.D., DABT, Associate Research Investigator, Cellular, Molecular and Exploratory Toxicology, Abbott Laboratories

A Protein Chip for Hepatotoxicity
Zhiyuan Hu, Ph.D., Research Scientist, Laboratory of Dr. Leroy Hood, Institute for Systems Biology, Seattle

薬物性肝障害の臨床評価

Human Drug Hepatotoxicity: A Contemporary Clinical Perspective
Victor Navarro, M.D., Associate Professor of Medicine, Department of Hepatology at Thomas Jefferson University, Philadelphia

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推奨ショートコース *

5月11日(日曜)午後 (SC1) 心臓への安全性: よりよい臨床結果のための前臨床予測

Improving Pre-clinical Predictions to Better Clinical Outcomes Cardiotoxicity is one of the major forms of toxicity seen in drugs and it accounts for most recalls and delays experienced in drug approvals. One of the biggest challenges is how to predict cardiac risk associated with drug candidates very early and accurately in the drug development process. This short course is designed to get researchers and clinicians to question the predictive validity of current cardiac risk assessment strategies and to get them thinking about ways to improve preclinical predictors of cardiac safety. This course will provide an overview of the recent technical and scientific advances in preclinical safety testing such as, improvements in assay design and reagents, availability of new cell lines for in vitro toxicity screening, use of toxicogenomics and other tools for developing safety biomarkers and the success of in silico predictive models for determining cardiac safety. The instructors will also talk about ways to then effectively combine the intelligence gathered from preclinical screens with clinical data and post-marketing pharmacovigilance studies from other drugs, to better assess risk to benefit ratios for new drug candidates.

* こちらのコースへの出席に際しては別途お申し込みが必要となります。
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